Fosun Pharma subsidiary's cancer drug application accepted

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its controlled subsidiary, Fosun Kite (Shanghai) Biotechnology Co., Ltd., has received acceptance from the National Medical Products Administration for the drug registration application of Brexucabtagene Autoleucel Injection (project code: FKC889). This 3.2-category biological product is for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).

The product, a CD19-targeted CAR-T cell therapy, was developed by Fosun Kite through a technology transfer and licensing agreement with Kite Pharma, Inc., a subsidiary of Gilead Sciences, Inc. The underlying therapy, Tecartus, has already received approval in the United States and Europe in July and December 2020, respectively. Fosun Pharma's cumulative R&D investment for this product, as of August 2025, totals approximately RMB 183 million (unaudited).

While the acceptance of the application does not impact current performance, future commercialization hinges on GMP compliance and drug registration approval. The company cautions investors that market demand, competition, and distribution channels will influence post-launch sales, introducing a degree of uncertainty. Another indication for the product, relapsed or refractory mantle cell lymphoma (r/r MCL), is currently in bridge clinical trial phase in mainland China.